Company News Feature

K2M Partners With Aussie/Kiwi Firm

Biloine W. Young • Tue, April 18th, 2017

K2M Group Holdings, Inc. of Leesburg, Virginia and LifeHealthcare Group Limited of Australia-New Zealand, after concluding a successful seven year partnership, have entered into a new five year supply agreement to distribute K2M’s spinal technologies. The partnership’s goal is to establish the number one spine market position in Australia and New Zealand.

K2M Group Holdings, Inc. is a producer of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, and commercialized complex spine and minimally invasive spine technologies and techniques to treat the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal and sagittal planes. The Balance ACS platform, in combination with the company’s leadership in the 3D-printing of spinal devices, enable K2M to compete.

LifeHealthcare Group Limited is an independent provider of healthcare solutions in Australia and New Zealand. The company works across specialized therapeutic channels bringing Australian and New Zealand healthcare professionals innovative medical devices.

Matt Muscio, LifeHealthcare’s CEO, stated, “I am very pleased to announce our new five-year contract with K2M through 2021. K2M is a globally recognized innovator in complex spine, having led the way in deformity and now minimally invasive and 3D-printed spine solutions. Through our partnership, we have delivered highly successful product initiatives and market leading education forums, such as Deformity Down Under. We look forward to working with Eric Major and the K2M team over the coming years to reach our shared aspiration of the number one market share position in the Australian and New Zealand spine market.”

K2M President and CEO Eric Major stated, “LifeHealthcare has been an important strategic partner of ours for many years and their established distribution presence and strong surgeon relationships have been instrumental in K2M’s strong market share growth in Australia and New Zealand. We are happy to announce our new agreement and look forward to offering innovative spinal technologies, such as our 3D-printed CASCADIA™ Lateral Interbody System, and our comprehensive Balance ACS™ platform focused on achieving three-dimensional spinal balance, to surgeons in this important international spine market.”

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K2M Cage, Bands and Connectors Cleared by FDA

Walter Eisner • Mon, July 10th, 2017

K2M Group Holdings, Inc. sandwiched two FDA 510(k) Clearances around the Fourth of July. One for a 3D printed corpectomy cage and, the other, for a spinal proximal fixation system.

On June 28, 2017, the company announced the clearance of the Capri Small 3D Static Corpectomy Cage System. Calling the clearance, a milestone for the company, the system is a first-to-market 3D-printed cleared corpectomy cage. It is also the company's third product group to feature Lamellar 3D Titanium Technology.

The system, according to the company, provides a surgical solution for stabilizing the thoracolumbar spine (T1 to L5) in cases of vertebral body resections resulting from trauma or tumor. Its porous structure and rough surface architectures are designed to allow for bony integration throughout an implant. The system’s lordotic options help support the anterior spinal column with the goal of achieving sagittal balance.

Michael Finn, M.D., a neurosurgeon and assistant professor in the University of Colorado Department of Neurosurgery, said the incorporation of pores into the endplates increases the surface area for fusion and presents the potential for bone to grow into the corpectomy cage.

The company says its 3D printing technology creates structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the corpectomy cages are grown through the "selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity. Lamellar 3D Titanium Technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the cage."

Nile Proximal Fixation Spinal System

The second FDA 510(k) Clearance, and CE Mark, was announced on July 6, 2017 for the company's Nile Proximal Fixation Spinal System, a spinal system specifically designed for proximal construct augmentation.

The fixation system consists of bands and connectors that may be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures at the proximal end of the construct. The CE Mark for the fixation system also includes the use of anchors, which are not cleared for use in the U.S.

K2M, Inc. Launches in Italy

Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, December 19th, 2012

Ciao, Italia! K2M, Inc. has announced the launch of the company’s MESA Spinal Systems and SERENGETI Minimally Invasive Retractor Systems in Italy.

The top-loading MESA Spinal Systems feature Zero-Torque Technology, applying zero torsional loads, or twisting forces, to the spine when locking the screw. The systems offer a variety of screw types, and, says the company, “revolutionary instrumentation.” K2M indicates that these systems are uniquely designed to address the most difficult correction maneuvers, while providing the surgeon the ability to one-step lock.

The SERENGETI Minimally Invasive Retractor Systems feature a flexible polymer Retractor, which provides direct visualization and access to the screw heads to allow for simplified rod insertion. The Retractor is inserted with the screw, allowing for one-step, percutaneous placement of the implants.

“The innovative MESA and SERENGETI systems allow surgeons increased flexibility in their intraoperative decision-making, meeting a wide range of current unmet needs in spinal surgeries. The availability of new technologies for surgeons presents significant short and long term advantages to Italian patients, ” said Stefano Boriani, M.D., director of the Department of Oncologic and Degenerative Spine Surgery, Rizzoli Institute, in the December 4, 2012 news release.

“The Italian launch of MESA and SERENGETI marks another important milestone in K2M’s mission to be the global spine market leader, ” stated Eric Major, K2M’s president and CEO. “We look forward to bringing K2M’s full portfolio of breakthrough products to Italy, as it is critical to our commitment to patient care around the world.”

Asked about the location and timing of the launch, Major told OTW, “Italy is a major European market with unmet needs for K2M’s innovative comprehensive portfolio, particularly our complex spine and minimally invasive product offering. This launch is part of our strategic focus on expanding the K2M complex spine and minimally invasive brands. We have a significant number of key opinion leaders that have been pushing us to enter the Italian market and we believe our products are a perfect fit. The market is very forward thinking in its adoption of new innovative technologies and our core products, such as MESA Rail, RAVINE, and SERENGETI, cater to the surgeons’ needs.”

First 3D Expandable Interbody System Cleared by FDA

Walter Eisner • Mon, June 26th, 2017

K2M Group Holdings, Inc. stakes claim to be the first leading spine company to market a 3D-printed titanium interbody device. Now the company is adding to its portfolio after receiving 510(k) clearance for its MOJAVE PL 3D Expandable Interbody System.

That clearance, according to a June 22, 2017 company announcement, allows the company to be the first-to-market with an FDA-cleared, 3D-printed expandable posterior-lumbar (PL) interbody system. The company also said it offers the most comprehensive portfolio of 3D-printed spinal devices.

The fusion device features K2M’s Lamellar 3D Titanium Technology and is designed to allow for independent control of the anterior and posterior height in the lumbar spine. The company says this is a new capability not available with any other product in the market today. Featuring infinite adjustment within the expansion range, the implant may be locked at any desired height and lordosis to aid in the restoration of sagittal balance.

Steven Ludwig, M.D., an orthopedic spine surgeon and professor of orthopedics at the University of Maryland Medical Center in Baltimore says the ability to provide independent control of both the anterior and posterior height separately "is desirable for the restoration of sagittal balance compared to existing devices that can’t independently adjust both anterior and posterior height.”

K2M's Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that, according to the company, "are impossible with traditional manufacturing techniques. Starting with a titanium powder, the MOJAVE PL 3D endplates are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity. Lamellar 3D Titanium Technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the endplates."

K2M President and CEO Eric Major said as the first-ever, FDA-cleared, 3D-printed expandable interbody technology, the system, "exemplifies our leadership in this space and provides surgeons the ability to expand the implant in-situ. This is our second family of products featuring Lamellar 3D Titanium Technology and builds upon the incredibly successful CASCADIA 3D family of static 3D-printed interbody cages.

K2M’s MESA Cleared for Kids With Spinal Deformities

Walter Eisner • Thu, September 22nd, 2016

K2M Group Holdings, Inc.'s MESA Spinal System has been 510(k) cleared by the FDA for patients under 10 years of age.

The clearance, announced on September 21, 2016 at the at the Scoliosis Research Society (SRS) 51st Annual Meeting & Course in Prague, Czech Republic, is good news for children who can now benefit from the hardware of screws and connector components of the system's rod construct to address their deformed spines.

According to the company, application features of the MESA system include closed-head screws and previously cleared axial connectors, providing a surgical solution for patients less than 10 years of age to obtain and maintain correction of severe, progressive, life threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis.

With this additional spine application, the company says surgeons can "utilize components from a traditional fusion construct for a growth-enabling construction, allowing implants to be surgically lengthened on a periodic basis as the patient grows. This growing spine application also offers a growth guidance option, combining standard instrumentation and placement of unlocked closed-head screws at non-fusion levels, to allow for rod passage as the patient grows."

The implants may be used with any cleared K2M rod construct ranging in diameter from 4.5 mm to 6.35 mm. K2M’s growth rod conversion implants may be used with 4.5 mm and 5.5 mm rod constructs.

Company President and CEO Eric Major said the regulatory milestone, "coupled with our recent data announcement of findings surrounding our motion-preserving scoliosis technology, reinforce our ongoing commitment to achieving the highest level of excellence in developing innovative technologies that provide enduring treatments for young patients suffering from complex spinal deformities, such as early-onset scoliosis and adolescent idiopathic scoliosis.”

In July, K2M announced findings from a multi-year study surrounding the company's acquired motion-preserving scoliosis technology from K-Spine. The study, said the company, found that the innovative apical fusion technique achieved corrected deformity profiles in AIS (adolescent idiopathic scoliosis) patients and maintained mobility of non-fused segments with a lower implant density, sparing 52% of the spanned area from fusion.

K2M Launches Everest at SRS’s 50th Annual Meeting

Walter Eisner • Wed, October 7th, 2015

K2M Group Holdings, Inc. launched its Everest deformity spinal system at the Scoliosis Research Society's (SRS) 50th Annual Meeting in Minneapolis the last week of September. It was the company's fourth product introduction in its complex spine portfolio in the past year.

According to the company, the system allows for faster insertion and increased pullout strength. It also removes the need for reduction screws, offers segmental reduction of the rod, and provides intraoperative flexibility.

Featured in the system is a top-loading pedicle screw with a variety of screw types and accommodates titanium and cobalt chrome rods in two different diameters. The Basecamp Deformity Rod Reducer instrumentation provides surgeons with multiple options during surgery in one system with 60mm of quick or controlled rod reduction.

Shay Bess, M.D., chief of adult spinal deformity in the department of orthopedic surgery at the NYU Langone Medical Center's Hospital for Joint Disease in New York, said the system "offers a streamlined and comprehensive approach and adapts to each surgeon's preferred surgical technique, thereby allowing me to make the appropriate surgical decisions for my adolescent and adult patients."

The system includes polyaxial and uniplanar screws, which feature a dual-lead thread pattern for faster insertion and increased pullout strength. The set screw features a modified square thread design that facilitates set screw introduction. The mixed-metal tulip minimized head splay and, according to the company, demonstrated improved biomechanical performance when tested against an all-titanium alloy screw.

Frank Schwab, M.D., spine service chief at the Hospital for Special Surgery in New York, said the speed and control Basecamp provides exceeds his expectations and gives him the ability to reduce the rod and correct the spine in a controlled fashion."

Eric Major, the company's president and CEO, said that along with Everest, the company has introduced the MESA 2 deformity spinal system, K2M's flagship product for adolescent idiopathic scoliosis, the Nile alternative fixation spinal system, a low-profile band fixation technology, and the Capri corpectomy cage system, a trauma- and tumor-focused system offering new, unique intraoperative functionality.